NICE seeks comment on PFO closure
This article was originally published in The Gray Sheet
Executive Summary
The U.K.'s National Institute for Health and Clinical Excellence is seeking comments by Aug. 24 on two separate consultation documents on percutaneous patent foramen ovale closure. The first document concluded there is evidence PFO closure is effective in secondary prevention of recurrent paradoxical embolism but also carries a "small incidence" of well-recognized adverse events. The second document finds evidence does not support PFO closure for treatment of recurrent migraine. The target date to publish both guidances is December, NICE says. AGA Medical is studying its Amplatzer PFO occluder in migraine and stroke; NMT Medical is developing the STARFlex PFO device for stroke, but suffered a setback recently when results of a clinical study showed the device was not superior to best medical therapy (1"The Gray Sheet" June 21, 2010)